- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05623475
Effects of Scenario-based Education Initiative and OSCE for Recognition and Management of Delirium
November 13, 2022 updated by: Taipei Medical University
Evaluating the Effects of Implementing a Scenario-based Education Initiative and OSCE for Recognition and Management of Delirium: a Cluster Randomized Controlled Trial
Delirium is a disturbance in consciousness with reduced ability to focus, sustain, or shift attention that occurs over a short period of time and tends to fluctuate over the course of the day.
50% to 81.7% had delirium during their ICU hospitalization.
Delirium is associated with increased physical restraint, ventilation use, length of ICU stay, and mortality.
However, there is no established delirium care pathway in target hospital.
Chen et al. (2014) demonstrated that structured assessment stations with immediate feedback may improve overall learning efficiency over an EBP workshop alone.
However, no published delirium care education study has used OSCEs as an intervention for healthcare professionals.
The aim is to evaluate the effects of implementing a Scenario- based education intervention, including objective structured clinical examinations (OSCEs) on delirium care among healthcare professionals.
This is a knowledge translation research, builds on eight years of delirium care research in University of Wollongong, Australia.
The research will be undertaken at ICUs in a medical center in northern of Taiwan.
There are two phases: (1) systematic review to identify delirium screen tool, and (2) a randomized controlled trial was conducted to determine the effects of implementing a Scenario-based education intervention, including OSCE (experimental group), and on-line education only (control group) focused on recognition and management of delirium.
The hypothesis is: Scenario-based education intervention, including OSCE can increase the competence and self-efficacy among healthcare professionals in delirium care.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
OSCEs are an integral aspect of all levels of medical education but limited to undergraduate nursing and allied health education.
OSCEs are rarely used in the workplace as learning activities with nursing and allied health clinicians.
This is the reason why this education initiative was innovative.
OSCEs are simulated 'real life' clinical scenarios presented to clinicians who are required to demonstrate to an assessor the clinical tasks which form an OSCE scenario.
Study Type
Interventional
Enrollment (Anticipated)
116
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kee-Hsin Chen, PhD
- Phone Number: 3613 +886-2-27361661
- Email: keehsin@tmu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 11031
- Recruiting
- Taipei Medical University Hospital
-
Contact:
- Kee-Hsin Chen, PhD
- Phone Number: 3613 +886-2-27361661
- Email: keehsin@tmu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Registered nurse worked in acute care unit and care with critical patients
- Licensed physician which undertake the post graduate year program worked in acute care unit and care with critical patients
Exclusion Criteria:
1.Unwilling to involved the research
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: experimental group
|
Scenario-based education intervention, including objective structured clinical examinations (OSCEs)
Face-to-face Education using Delirium Care Flip Chart
Including 7 parts of delirium care video
|
ACTIVE_COMPARATOR: control group
|
Face-to-face Education using Delirium Care Flip Chart
Including 7 parts of delirium care video
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delirium Knowledge and Skills Test (included 18 questions)
Time Frame: T0(Baseline), T1(Immediately after the intervention), T2(Six weeks after the intervention)
|
Change from Baseline Delirium Knowledge and Skills at the time Immediately after the intervention and Six weeks
|
T0(Baseline), T1(Immediately after the intervention), T2(Six weeks after the intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kee-Hsin Chen, PhD, Taipei Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 25, 2021
Primary Completion (ANTICIPATED)
January 31, 2023
Study Completion (ANTICIPATED)
June 30, 2023
Study Registration Dates
First Submitted
November 13, 2022
First Submitted That Met QC Criteria
November 13, 2022
First Posted (ACTUAL)
November 21, 2022
Study Record Updates
Last Update Posted (ACTUAL)
November 21, 2022
Last Update Submitted That Met QC Criteria
November 13, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N20210318
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on OSCEs
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